PharmaShots Weekly Snapshot (May 13–17, 2019)

1. Roche Signs a Worldwide License Agreement with Parvus Therapeutics to Develop and Commercialize Navacim Platform for Autoimmune Diseases

Published: May 16, 2019 | Tags: Roche, Signs, Worldwide, License, Agreement, Parvus Therapeutics, Develop, Commercialize, Navacim Therapeutics, Autoimmune Diseases

2. Exelixis Signs an Exclusive Option and License Agreement with Iconic Therapeutics for Advancing ADC Program

Published: May 16, 2019 | Tags: Exelixis, Signs, Exclusive, Option, License, Agreement, Iconic Therapeutics, Advancing, ADC Program

3. Pfizer’s Fragmin (dalteparin sodium) Receives FDA’s Approval for Symptomatic Venous Thromboembolism in Pediatric Patients

Published: May 16, 2019 | Tags: Pfizer, Fragmin, dalteparin sodium, Receives, FDA, Approval, Symptomatic Venous Thromboembolism, Pediatric Patients

4.Thermo Fisher to Acquire Manufacturing Facility from GSK for ~$100M

Published: May 16, 2019 | Tags: Thermo Fisher, Acquire, Manufacturing Facility, GSK, ~$100M

5. Sanofi and Regeneron Report Updated Results of Libtayo (cemiplimab-rwlc) in P-II EMPOWER-CSCC-1 Study for Locally Advanced and Metastatic Cutaneous Squamous Cell Carcinoma

Published: May 16, 2019 | Tags: Sanofi, Regeneron, Report, Updated, Results, Libtayo, cemiplimab-rwlc, P-II, EMPOWER-CSCC-1, Study, Locally Advanced, Metastatic, Cutaneous Squamous Cell Carcinoma

6. GSK Expands its License Agreement with Zymework to Develop and Commercialize Bi-Specific Antibodies

Published: May 16, 2019 | Tags: GSK, Expands, License Agreement, Zymework, Develop, Commercialize, Bi-Specific Antibodies

7.NeuClone to Initiate P-I Clinical Study of Stelara (ustekinumab, biosimilar) in Australia

Published: May 15, 2019 | Tags:NeuClone, Initiate, P-I, Clinical Study, Stelara, ustekinumab, biosimilar, Australia

8. Takeda and Frazier Healthcare Collaborate to Launch a Facility Phathom Pharmaceutical for Gastrointestinal Disorders

Published: May 15, 2019 | Tags: Takeda, Frazier Healthcare, Collaborate, Launch, Facility, Phathom Pharmaceuticals, GI disorders

9.Roche and AbbVie’s Venclexta (venetoclax) + Gazyva (obinutuzumab) Receive FDA’s Approval for Untreated Chronic Lymphocytic Leukemia

Published: May 16, 2019 | Tags: Roche, AbbVie, Venclexta, venetoclax, Gazyva, obinutuzumab, Receive, FDA, Approval, Untreated, Chronic, Lymphocytic Leukemia

10. Vertex Signs a 4 Years Agreement with Kymera to Discover and Develop Protein Degradation Therapies

Published: May 15, 2019 | Tags: Vertex, Signs, 4years, Agreement, Kymera, Discover, Develop, Protein Degradation Therapies

11.REGENXBIO Launches a Manufacturing Facility for Developing Gene Therapies Based on NAV-Technology

Published: May 15, 2019 | Tags: REGENXBIO, Launches, Manufacturing Facility, Developing, Gene Therapies, Based, NAV-Technology

12. Progenics Signs an Exclusive Agreement with ROTOP Pharmaka to Develop and Commercialize Imaging Agent 1404 for Prostate Cancer in Europe

Published: May 14, 2019 | Tags: Progenics, Signs, Exclusive, Agreement, ROTOP, Pharmaka, Develop, Commercialize, Cancer Imaging Agent, 1404, Prostate Cancer, Europe

13. Abbott Collaborates with NIH on Brain Initiative for Advancing Research on Neurological Disorders

Published: May 14, 2019 | Tags: Abbott, Collaborates, NIH, Brain Initiative, Advancing, Research, Neurological Disorders            

14. Merck KGaA and Pfizer’s Bavencio (avelumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

Published: May 14, 2019 | Tags: Merck KGaA, Pfizer, Bavencio, avelumab, + Inlyta, axitinib, Receive, FDA, Approval, 1L, Treatment, Advanced, Renal Cell Carcinoma

15. Myovant Sciences Reports Results of Relugolix Combination Therapy in P-III LIBERTY 1 Study for Uterine Fibroids in Women

Published: May 14, 2019 | Tags: Myovant Sciences, Reports, Results, Relugolix Combination Therapy, P-III LIBERTY 1, Study, for Uterine Fibroids, Women

16.AliveCor’s KardiaMobile 6L Receives FDA’s Clearance as Six-Lead Personal ECG Device

Published: May 13, 2019 | Tags: AliveCor, KardiaMobile 6L, Receives, FDA, Clearance, Six-Lead, Personal, ECG Device

17. HanX Biopharmaceuticals Signs a License Agreement with Onconova to Develop and Commercialize Rigosertib in Greater China

Published: May 13, 2019 | Tags: HanX, Signs, License, Agreement, Onconova, Develop, Commercialize, Rigosertib, Greater China

18. Exelixis and Daiichi Report Launch of Minnebro (Esaxerenone) Tablets for Hypertension in Japan

Published: May 13, 2019 | Tags: Exelixis, Daiichi, Report, Launch, Minnebro, Esaxerenone Tablets, Hypertension, Japan

19.Regeneron’s Eylea (aflibercept) Injection Receives FDA’s Approval for Diabetic Retinopathy

Published: May 13, 2019 | Tags: Regeneron, Eylea, aflibercept, Injection, Receives, FDA, Approval, Diabetic Retinopathy

20. Roche Launches Cobas MTB-RIF/INH Test for the Detection of Antimicrobial Resistance in Tuberculosis

Published: May 14, 2019 | Tags: Roche, Launches, Cobas MTB-RIF/INH Test, Detection, Antimicrobial Resistance, Tuberculosis

21.The US FDA Issues Final Guidance on Interchangeable Biosimilars

Published: May 10, 2019 | Tags: The US FDA, Issues, Final Guidance, Interchangeable Biosimilars

22. Boston Scientific Reports Results of Emblem S-ICD System in UNTOUCHED Study to Prevent Sudden Cardiac Death

Published: May 10, 2019 | Tags: Boston Scientific, Reports, Results, Emblem S-ICD System, UNTOUCHED, Study, Prevent, Sudden, Cardiac Death

23. Novartis Voluntary Nationwide Recalls Three Lots of Promacta (eltrombopag, 12.5 mg) Oral Suspension Due to Peanut Contamination

Published: May 11, 2019 | Tags: Novartis, Voluntary, Nationwide, Recalls, Three, Lots, Promacta, 12.5mg, Oral Suspension, Peanut Contamination

24. Eli Lilly’s Cyramza (ramucirumab) Receives FDA’s Approval as a Second-line Treatment in Patients with High AFP Hepatocellular Carcinoma

Published: May 10, 2019 | Tags: Eli Lilly, Cyramza, ramucirumab, Receives, FDA, Approval, Second line, Treatment, Patients, High AFP, Hepatocellular Carcinoma